FDA Ban on Vaping: The Ugly Truth

The Issue

The FDA has declared war on vaping. The deeming regulations aren’t rules any vaping business can work with. They’re an attack on what we do and who we are, and vapers are right to feel mad and betrayed. The regs are as bad as the most pessimistic advocates expected — or maybe even worse.

Don’t let anyone kid you. If you’re a manufacturer or seller of vapor products in the US, this is a death sentence for your business. And if you’re a consumer of anything other than cigalikes, it’s going to reduce your choices of legal products to almost zero. As it stands, on August 8 the vaping market will be frozen. You will not be able to make or sell any new products without approval from the FDA. Beyond that, vendors will have two years to file their pre-market tobacco applications. Each application for approval to sell “tobacco products” will probably cost over a million dollars, and there is no guarantee it will be accepted by the FDA.

The requirements are extreme. Aside from exacting scientific studies, you will have to prove that your product has a net benefit to the overall public health. It’s an impossible standard to meet. If you don’t have several million dollars to gamble with, you can’t survive if these regulations go into effect. That’s intentional on the FDA’s part. They know we can’t live in the world of extreme and exacting tobacco regulations and compliance. Our only hope is to stop the regulations from choking the thing that we love and depend on.

The Vapor Technology Association has a pretty good summary of what we know so far. And Mark Dickinson of Clarityse sums it up neatly: “The sheer scale of the regulatory burden is very likely to be the death knell for the huge majority of independent manufacturers and vape stores in the US, with almost all products currently available being taken off the market in 2-3 years time. It will also bring to an immediate halt all the US based innovation that has been so prevalent in the last few years.”

While claiming to protect children from nicotine addiction, Mitch Zeller and his agency have delivered a carefully crafted ban of all vapor products, except perhaps cigalikes made by Big Tobacco. They justify this by quoting the National Youth Tobacco Survey (NYTS) that shows vaping among teenagers growing. But they ignore the National Institute on Drug Abuse survey that showed only 20 percent of teens use nicotine in their e-cigs. The NYTS surveys don’t even ask whether kids use nicotine — or if they’re regular users or have just taken a single puff in the last 30 days. How convenient! They also ignore that all surveys show teen smoking at its lowest level ever. It’s not about smoking anymore; the objection is now to nicotine itself.

The FDA specifically says that nicotine in pharma products like patches and gum is not addictive or dangerous. But they ignore all evidence that the same may be true of nicotine in vapor products and couch their regulation in the lie that they’re protecting kids from “a lifetime of addiction.” If your company’s name is Pfizer or Johnson & Johnson, your tobacco-derived nicotine is a safe, non-addictive medicine. If your name is Joe’s Vape Juice, you’re a producer of deadly addictive poison that is a menace to society.

The age limit on buying vapor products that goes into effect on August 8 is window dressing. 48 states already ban sales to minors (and the others don’t because “health groups” fought against the minor bans because they wanted other restrictions included). But the FDA is playing this as an example of “protecting children.” And most of the mainstream media is swallowing it whole.

Meanwhile, the most dangerous consumer product in the history of the world will remain available and protected from competition. Adult smokers desperate for a way out will have the option of buying ineffective junk from the same companies that make the cigarettes that are killing them — or, if they want to jump through hoops and skirt the law, they can seek out black market vape products. Many will just keep smoking.

The FDA wants to hand the vapor market to the supposed enemies of tobacco control on a silver platter. Call it a gift, a token offering to the tobacco industry that has learned to play so well within the restrictive regulatory framework they built together. The FDA loves Big Tobacco, but not because of bribes or collusion. It’s because they speak the same language and inhabit the same world — the world of legalistic government business regulations. The tobacco industry knows how to play this game, and has the resources available to play it.

In the UK, voices of logic have won the day. Public Health England and the Royal College of Physicians have advocated a harm reduction approach that includes encouraging smokers switching to vaping to avoid cigarettes. The FDA, afraid of criticism from their friends in the pharma-funded anti-nicotine “health” groups, went in the polar opposite direction: prohibition.

So, Is It All Over? Should We Pack up Our Mods and Buy a Pack of Camels?

No! We still have avenues open to fight this thing. But everyone needs to stop pretending that this pathway of pre-market applications and substantial equivalence is one we can walk. The deemings regs are a ban, plain and simple. But we need to get busy and act now. We have to get embrace the fact that we are the only ones who have a chance to stop the deeming ban from killing vaping as we know it. No white knight is riding in to protect us. What should we do now? Here’s what:

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I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.

I agree, Jim. The FDA pronouncement is a de facto attempt to kill the independent vaping industry in America. The “approval process” is a mockery of sane regulation that amounts to a death sentence for tens of thousands of small businesses, from the crudely-disguised impossible financial requirements of the approval process to the guilty-until-proven-innocent burden of proof.

It’s despotic overreach in the most galling sense, with money and power at its core — public health be damned. The bogus appeal to “protecting the children” is particularly offensive.

Since the announcement, I’ve been horrified to read and hear online and on TV knee-jerk support for the FDA’s action from commentators who are shockingly misinformed and echoed by random citizens who clearly know absolutely nothing about vaping. I’m sure the FDA and Big Tobacco are immensely pleased with themselves. Suddenly it’s 1919, with the idiocy of Prohibition all over again.

This is war, plain and simple.

Smithatude

Unfortunately, this is what regulations do to small businesses. They skirt legislation, and make up rules. I hope it all gets beat back. Regardless, everyone needs to know that these regulations that are enacted, not passed into law are killing this country. RJ Reynolds, or Reynolds American (RAI) had to sell its live of “Blue” ecigs a while back to buy another big tobacco company. They are locked and loaded to take over the VAPE market probably by buying up small, successful companies for cheap. They may be able to pick and choose the best companies to “save” while offering jobs to those who are talented and can help in R&D.

They want to ban carbon dioxide (don’t tell the trees) but no one talks about banning ciggarettes. I wonder why that is.

Jim McDonald

Actually Lorillard had to sell Blu before the SEC would approve Reynolds’ purchase of Lorillard.

Taylor Wenslow

The most disgusting part is that in all reality prohibition of substances or consumer products is actually unconstitutional and a gross, undeniable violation of our rights as American citizens, and our human rights as citizens of Earth.

Gio

Why isn’t anyone trying to Ban Cigarettes?, and is it possible?, there has to be a way to hit big tobacco where it hurts after they did this to us.

Jim McDonald

Cigarettes were grandfathered in under the Tobacco Control Act of 2009. The FDA can’t make them illegal. Forget Big Tobacco — who is NOT responsible for these regulations — and get involved doing what will help us now — supporting HR 2058 and the Cole-Bishop amendment to the appropriations bill, and also the Right to be Smoke-Free Coalition lawsuit.

usvietnamvet

Why should they ban cigarettes? As adults we should be able to choose what we use.

I grew up around 2nd hand smoke (50’s/60’s) as did most kids. Why don’t we have asthma in the numbers today’s kids have it? Most adults smoked, even pregnant women, why not tons of symptoms/disease there too?

Shouldn’t smoking be a choice for any adult? What ever happened to the concept of an adult being allowed to make their own decisions?

Howard W Fisher

Ill just go back to smoking and cost health care services millions of dollars when i get cancer. I refuse to vape government regulated e cigs and liquids

I disagree on petitions; they lead to nothing. I’d suggest instead going to http://www.August8th.org and using CASAA’s quick and easy contact tool to send letters to your Congress members. They are the only ones who can change the deeming predicate date — and they DO read letters from constituents. Petitions not so much.

Michael Abrams

As a health care advocate, I would say less than 5 percent of change comes willingly. Our best hope, imho, is on the legal front, compelling those responsible for this bill to produce evidence, not emotion fuel by junk science and commentary from father knows best figures, medical or otherwise.
As it is now, the tail is wagging the dog.

usvietnamvet

I don’t smoke or engage in vaping, but I’m sick of the FDA and the DEA. Shouldn’t we as adult Americans be able to live our lives as we wish as long as we don’t infringe on the rights of other citizens?

Let’s face it the FDA actually stands for Freedoms Denied to Americans!!!

My husband is a smoker and they’re taxing his smokes to the point we may not be able to afford them. When he doesn’t smoke (he stopped for over a year and we almost got divorced) he changes from a wonderful person to a horrible person. As adults we should be able to decide for ourselves what we want. I’m sick of the Nanny State.

i wonder how much did tobacco companies pay the FDA to stop the vaping market. if that happens. well. back to smoking. fuck!!! what a waste of money, i dont think id smell good no more, id smell like an ashtray and im prone to death. if i get lung cancer due to smoking. Ill sue you FDA for banning e-cigs. mark my word!!!

Blasted

Don’t give tobacco companies any more money.

walkman321

I personally think tobacco should be classified as as schedule one drug. It has a greater addiction than any drug on the schedule one list and has killed more people than all the schedule one drugs grouped together

Jim McDonald

So, since vapor products are now considered tobacco, you want e-liquid also classified as a Schedule One drug?

Rob

Well, if you’d stop pretending this pack of lawless criminals is a “government” with some sort of “authority,” it would concern you as little as their nonsense concerns me. The way to get this syndicate back under control starts with telling them, “NO!”

DJTWILLWIN

Vote for Trump he will stop this cold I know him and he will say it does not make sense!

Jim McDonald

Trump hasn’t said anything about vaping at all. Nobody has a clue what he would do. *He* can’t even decide from one day to the next what he stands for.

Pamela

Don’t go back to smoking cigarettes, that’s their whole plan. They want you to quit putting your money to the better alternative and start putting it back into big tobacco. The whole reason for this is the loss of money that the tobacco companies are losing!! That is just my opinion but don’t give in and go back to smoking cigarettes.

T.Moose

The FDA is just looking for money. Plain and simple. They are losing money because people are finding alternative to smoking cigarettes and the FDA does not like that. So what are they gonna do? Ban e-cigs. The FDA is a bunch of money hungry bunch of ignorant politicians. There is evidence and proof that e-cigs are a great alternative to smoking cigarettes. But you know damn well they don’t care about that or the people. All they care about is the money that gets stuffed back in their wallets so they can buy that expensive yacht or that 23 bedroom house. “We care for the well being of the American people”. That’s a load of bull. If you cared SOOOOOOOO much for the American people then why are you not taking in this proof and evidence and make a difference? Oh that’s right you won’t be able to buy that yacht or that wonderful house you had your eye on. These people are not informed enough to make such decisions. They hear one thing and they run with it. E-cigs should be regulated because they are a “tobacco product”. Okay if that’s the case then what about the nicotine patch? Nicotine chewing gum? Or the lozenges? Are those regulated? Nope. They don’t need to regulate those because the top cigarette companies supply them with enough money for them to turn a blind eye. We need people to stand up and voice their opinions. We need people to scream and shout and with enough people, we can start something. We can be an unstoppable force that the FDA will have to stop and be forced to listen to our concerns, our opinions, our views, hell our well being. We need more people to make a stand. We need you to be more proactive. We need you, the people, to spread the word.

Eaddie Hall

How the hell is it protecting the children when they can have access to cigarettes it’s all part of the tobacco industry losing money and health care for people not getting cancer

usvietnamvet

I grew up around 2nd hand smoke (50’s/60’s) as did most kids. Why don’t we have asthma in the numbers today’s kids have it? Most adults smoked, even pregnant women, why not tons of symptoms/disease there either.

Shouldn’t smoking be a choice for any adult? What ever happened to the concept of an adult being allowed to make their own decisions?

As far as kids smoking, any adult giving kids smoking products should go to prison. My husband and I didn’t smoke while the kids were growing up. One adult child smokes the other doesn’t. Exactly HOW are kids getting access to cigarettes? It’s against the law and they enforce it. Exactly how are they supposed to stop kids from stealing cigarettes (which is the way most kids get them)? Your last statement doesn’t even make sense.

tomanonymous

HEY FDA, I TOLD YOU BASTARDS 6 YEARS AGO!

This WILL NOT STAND!!!

Vaporenu.com sells 5 gallons of e-juice for $400
Stock pile people!
It’s time to stockpile…
AT THIS POINT, CIVIL DISOBEDIENCE is our ONLY OPTION!!!
Maybe we should reenact the Boston Tea party. But replace Tea with Tobacco.
Yes, I mean get a bunch of cigarettes and DESTROY THEM!!!
No tax money for you greedy bastards.

Vapingkitty

Can we still buy from China importers like fasttech, or make our own juice?

Jim McDonald

You can still buy from anywhere, just nothing new — for two years. After that, we’ll see. So far there is no regulation on DIY.

Poruchik Rzhevskiy

The moment any new product threatens the revenue of large corps, it is immediately “regulated” to death. Yet another evidence that FDA is owned and paid for.

Logical Lunatic

I smoked for 30 years. I vaped for one year, continually decreasing my nicotine levels, and finally managed to quit entirely a year ago.

In short, vaping helped me quit smoking. I find it pathetic that the very same people who allow big tobacco the opportunity to kill millions of people seek to ban what is obviously a safer solution that could lead to quitting altogether as it did in my case. Corruption knows no shame it seems.

Goddamn i hate centralized government.

Anonymous IceCube

How about presenting the fact that Cigarettes are the most littered item in the WORLD and on top of that Vaping initially eliminates the second hand smoke issue (that people, people’s pets, and children are exposed to and sometimes get cancer and die from). On top of that Vapes don’t have the same offensive smell that cigarettes do (If you smoke you may love it, but a non-smoker can smell it a mile away). Cigarettes have been proven to cause cancer and while vaping presents the same possibility, it does in fact cut down on the plant resins that accumulate in your lungs (common with tobacco), and also you don’t have to worry about fires being started by “irresponsible Vapors”. A simple night of research on the topic shows that not only are vapes better for the people using them and the people around them, but also the environment seeing as how people don’t go throwing their mods on the ground at every corner in the city.
In my personal opinion this is a stupid decision the FDA is making just based on common sense. Yes their should be regulations in place as their are with all tobacco and nicotine products but at the same time the general public has seen great progress from vapes and high priced papers and regulatory documentation giving one the right to sell vapor products is just irrational in comparison to how much they charge say a tobacco shop to sell their death sticks.

Just the fact that keeping vaping alive and a alternative to smoking just to cut down on the littered cigarettes is enough to say that they help society. Its not like every city hires people to pick up every last cigarette but on the ground, and most of them end up in our soil and in landfills which is exactly why their pieces of trash.

All this act will do is cause post-vapors to stock up on liquid and coils, become better at building home-made coils and mixing homemade juice which will then be sold as a black market item. On top of that what are they ganna get rid of the ones used for hash oil in Colorado and legal marijuana states? These devices may just be modified for use with VG and PG (some of them are allready compatable with these) by people looking for something better than cigs.
People will find a way. They always do and we always have. All this will do is create a generation of minds set on building their own vaping gear cause let me tell you if you switched to vaping and you like it, chances are your not ganna let something like the FDA tell you what stores you can go to and what flavors you can vape.

Jim McDonald

Yes, existing vapers will find a way. The problem is that people who haven’t already switched to vaping will have a hard time entering a black market. Most people have no interest in jumping through those hoops.

The Salmon Of Doubt

Yip. Sounds about right:

Ecigs invented in China.
Innovation through usage and competition in US/Europe.
Small/independent manufacturing squeezed out through lobbying in US/Europe.
Manufacturing/profits stay within China.

Both US/Europe consumers AND business screwed.

And everyone talks about why the West is constantly losing ground to the Chinese? Construction, Automobiles, White Goods, damn even vaping.

Jim McDonald

Well, maybe. However, the Chinese manufacturers won’t exactly prosper if they can’t sell within the United States. They have to comply with the deeming regs too.

The Salmon Of Doubt

I work and live in Hong Kong. Recently, Hong Kong banned “nicotine” products that weren’t regulated, I mention this because it may be an example of the situation in the US.

Many years (8 or 9) back I tried ecigarettes in their infancy. In China (where these things were invented) they originally propped up as a sort of gag. Nobody really took them seriously except as a novelty. I tried them because I dreaded smoking fake Marlboros on visits to China. And to be needlessly honest, also for the thrill of an occasional puff in the airport loo. If you share a background of smoking, I think you can imagine it.

The concern [for me] isn’t whether its China or America or Iceland [to pick a place at random]. Spot on, without the US, the largest vaping market, manufacturers in China and America (and Iceland) won’t have a significant demographic to sell to.

Supply requires demand.

Demand is brought about through innovation.

My main concern is the result this will have on this innovation and progress. Perhaps like alcohol, nicotine ought to be free market as consumers are going to try quite hard to get their smokes and vapes. With free market a consumer can make informed decisions from a panoply of options – manufacturers and middlemen that want to be competitive respond accordingly.

From that viewpoint of innovation vaping was primed to take off as an industry. For 75 years the tobacco sector brought such limited innovation to the point where it’s an interesting question to ask if the big established smoking companies were doing it intentionally? We all knew it was addictive, we all knew it was cancerous, and about a decade or two back it also became hugely expensive and nothing about the manufacturing changed. Smokers went on smoking, aware what they were doing to themselves and the people in their lives. Manufacturers went on making them shrouded in secrecy. For all the emphasis made on food packaging and labeling it’s remarkable the same did not happen with the tobacco sector.

But we aren’t quite in the same world anymore. A global economy and the internet allowed for some interesting collaboration and partnerships. Vaping, pertinent to this discussion, exploded. Innovation in these few short years has been astounding; one mod after the next, one juice brand on the heels of another. At this moment I’m sampling juice from a Croatian startup that would never have existed a few years back.

Already much of the hardware is made in China. When you look closely at many liquids [picture attached of a V2 bottle ordered from the source that makes for them] much of it also comes from China and is branded America (or Iceland).

It is this global economy, and the internet, that allows me to continue smoking/vaping in Hong Kong – despite it’s strict policy on imports of nicotine. I can’t order from JUUL and I can’t order from V2 and I can’t order from many shops in the US [credit cards, inane international shipping policies, inane courier declarations] but interestingly, I can order direct from the sources that make for them in China.

Now that vaping has innovated to some extent with this policy in the US it becomes a bit like the situation in Hong Kong. Everyone will order direct from China, from source, and Chinese vendors will “innovate” front end e-shops. The home engineer and crazy lab guy thinking of all the wonderful flavours will be left to hang.

This isn’t to say that innovation can’t continue happen, it just won’t happen at the pace we’ve come to like about our little vaping community. And a bit sadly, it might soon in principle be driven by economics and profits, and manufacturing efficiency. Less by the need of pushing the next best idea or flavours out.

The stuff is already made in China, perhaps after these regulations are brought about it might also be sold from China.

I believe very strongly in consumer rights and information, all that was needed was perhaps some clearer labeling of the contents on these bottles and juices. It would certainly help me bring in my 0% nicotine bottles from juice masters.

Jim McDonald

This is one of the best comments I’ve seen on Vaping360 about anything. Thanks so much. I hope you’ll find time to comment on other stories in the future.

The Salmon Of Doubt

Thank you Jim, the sentiment is appreciated on this fine evening here in Ljubljana. I’ve been in Slovenia the past couple of months tuning some of my tennis issues.

I’ve had the opportunity on this visit to familiarize myself better with vaping; both because the time [new place, don’t know many people, tennis is only 2-3 hours] and also because vaping is openly practiced here, which sparked greater curiosity – during this period your site has been an invaluable resource to learn more on the subject and industry.

It’s a wonderful initiative and effort you’ve made. Reviews of products and vendors are always helpful but these can also be found commonly across the internet. Less commonly found is your emphasis on the legality and legislative side. I’m happy to tell you that I have become a more informed vaper because of your initiative and efforts.

Also, sorry for the recent loss; Gordie Howe was a transcendent man. I grew up with Bossy, Potvin, Messier, Gretzky, Coffey, Fuhr, Lemieux, Hawerchuk et al – Mr. Hockey’s influence was right there in every conversation and every comparison. When he slipped away I felt it just as sharply as Ali’s passing.

Jim McDonald

Thanks for the compliment. The editors at Vaping360 believe strongly in offering a range of vaping content, including news and advocacy content. I feel glad to have found them, and hearing that people care makes it even better.

Thanks also for the comment about Gordie.

Mr.Flying Zoom3rz

Just order from China, it’s that simple. Fasttech will never care and won’t stop shipping vaping stuff all over the globe. Stupid bureaucratic regulations all over the course! In EU we can’t get 100mg/ml nicotine base because of some safety reason, now in US you get this shit. These fat ugly tobacco manufacturers just wanna bring us back to the cigs they’re selling. No!

gtc

You know why this matters to me so much? Because the TRUTH is that nicotine, without the shtty tar and stinky smoke and yellow fingers… is on par with caffeine. AND I wonder how many of those big tobacco lawyers wake up to several cups of java…. yes if they treated coffee production in this way, it would be a national travesty. A public uproar .and that’s even without millions of people SMOKING coffee beans, to their hypothetical, painful, early demise.

Indeed, this is nothing more than a hostile takeover. But.. back to why it’s so important to myself. I smoked two packs a day of Marlboro reds for the last 12 years at least, and a pack a day for 8 years before that. I hated it… I knew I was killing myself with tar and carcinogens from combustion. And now my kids are old enough to actually tell me… daddy. . Stop smoking. I mean, this affects what I’m able to afford. .includng healthy food for them. I would sometimes go to great and sometimes disgusting lengths for this drug, including spending 500 a month.

Well I haven’t smoked a cigarette in two months. And they want to dictate to ME what’s best, what I can or can’t do. This oligarchal, statist regulatory bllsht.

We cannot stand for it. ..must fight this tyranny. And educate people that THIS IS NOT SMOKING.

Jim McDonald

Well said. Thanks!

Charles Bell

If it comes down to it and I can’t vape, I won’t go back to cigarettes plain and simple. I’m not falling into their scheme. I’ve quit before and I’ll do it again. If you want to put your politics on my freedom and happiness and think that I’ll be swayed to go to one side that I don’t even like then you lose bud. They win if I buy a pack.

Samuel Ciraulo

The FDA and ADA are complete scumbags they infringe on our freedoms they take everything they can from us which makes perfect sense considering that they are part of our stupid government. This tastes similarly to cannabis prohibition and we all know what a great fucking success that was. Now this goes back to greater issues since the government has the ability to prohibit certain kinds of possessions from the public we should have suspected and truly we should have known that almost everything if not everything the government dies is done in the pursuit of funds, everything they do they do to make more money they don’t give a damn about public health, which is why they made cannabis illegal for the pursuit of different fabrics in place of hemp, and now they are making Vaping practically illegal because Big Tobacco is in bed with the FDA and thus are sharing profits, not to mention the profits they get from cancer and copd medication from big pharma. They don’t give a fuck about public health all they care about is money they belong in prison.

Duane Wood

It’s simple really. After big tobacco gets the government to destroy the small business dominated vaping industry, big tobacco will step in and take over. You will still be able to get juice but your 30 ml bottle will be $40.00 from RJ Reynolds or Liggett. Is this a great country or what!

Chris plain

Vaping is poison and all u mindless addicts should find something else to do or just keep killing yourself slowly